Volume 214 Issue 6

Putting in place the mechanisms to assess coverage in vulnerable groups is essential to drive optimal uptake and best practice Several targeted vaccine programs introduced to the Australian National Immunisation Program (NIP) in 2020 exposed the limitations of the Australian Immunisation Register (AIR), particularly, its inability to collect information on medical risk factors to monitor vaccine uptake in at‐risk groups. These program changes highlight the need to optimise AIR reporting to improve the accuracy of individual‐level vaccination data for the benefit of patients and treating clinicians as well as the ongoing surveillance of vaccine coverage for medically at‐risk groups. As of 1 July 2020, Bexsero (GSK), the meningococcal B vaccine, was funded by the NIP for all Aboriginal and Torres Strait Islander children aged under 2 years and for other populations with specific medical risk factors, including asplenia, hyposplenia, complement deficiency, and use of eculizumab therapy.1 Additional doses of the pneumococcal 13‐valent conjugate vaccine (Prevenar 13, Pfizer) and the 23‐valent pneumococcal polysaccharide vaccine (Pneumovax 23, MSD) are now funded for Aboriginal and Torres Strait Islander people and for individuals with certain medical risk factors (eg, asplenia, immunosuppressive conditions, specific respiratory disorders).2 While these NIP changes are welcomed, clinicians need access to data that include information on medical risk to optimise benefits to patients. Both patients and medical practitioners need capacity to track receipt, ensuring that the most vulnerable people receive the recommended vaccines, and avoid unnecessary repeat vaccinations. Assessing compliance with these policy changes will be difficult because medically at‐risk individuals are currently unable to be identified on the AIR. The functionality of the AIR needs to change to enable the collection of medical risk factors, including pregnancy, and strive for more complete reporting of vaccinations that will deliver benefits at both a population and individual level. Accurate coverage data are vital for clinicians to be able to offer evidence‐based care and ensure their most vulnerable patients are protected, and to inform strategies to improve vaccine uptake. Globally, the strongest predictor of influenza vaccine receipt in pregnant women and children with medical comorbidities is a health care provider recommendation.3,4,5 Facilitating health care provider recommendations and other effective strategies to improve uptake, such as reminders or prompts for clinicians or text messages from clinicians to patients, will not be optimal without accurate vaccination data. In this article, we aim to highlight the need for optimising reporting to the AIR and increasing its capacity to collect information on medical risk factors, ensuring maximum program reach of targeted programs, and propose potential solutions. Lower uptake of targeted vaccine programs Despite targeted vaccine programs aiming to improve coverage for vulnerable groups, they often have lower uptake than universal vaccine programs.3,4,6,7,8 With the exception of Aboriginal and Torres Strait Islander people, the AIR currently fails to recognise people who qualify as vulnerable because the AIR does not capture “at‐risk” status, rendering the eligible group (ie, denominator) not easy to identify. Before 2016, the Australian Childhood Immunisation Register only recorded childhood vaccines up to 7 years. With the expansion to the whole‐of‐life AIR in September 2016, it was hoped that adult vaccinations, including maternal influenza and pertussis vaccines for pregnant women and vaccines for medically at‐risk groups, would be captured. This is an ongoing priority because the uptake of maternal influenza vaccine remains suboptimal, estimated to be 39% in Victoria between 2015 and 2017,6 with variation nationally across years and jurisdictions — 31.7% (Northern Territory, 2016), 54% (New South Wales, 2016) and 76% (South Australia, 2017).8,9,10 Similarly, influenza vaccine uptake in medically at‐risk children also remains suboptimal (about 40% nationally for 2014–2015 and 2017).3,4 Lack of recording of at‐risk status At present, there is no capacity to link vaccine receipt on the AIR with a person’s at‐risk status, as the register lacks the functionality to do so. There is a need for the AIR to be able to more accurately track vaccine receipt nationally to identify strategies to improve coverage in at‐risk groups. The lack of pregnancy status capture in the AIR necessitates the use of other data sources, such as perinatal datasets in jurisdictions where maternal immunisation is collected, or population surveys to obtain coverage estimates, but these are of no use to clinicians at the individual level. This is also the case for children who are medically at‐risk, with no capacity to link medical risk factors with vaccine receipt for identification and tracking of these children. Parents are known to over‐report vaccination status, particularly for children with complex and ongoing medical conditions.11 Identification of at‐risk status would also enable more targeted estimates of vaccine effectiveness for at‐risk individuals, rather than extrapolating from population‐level data, enabling more comprehensive assessment of targeted vaccine programs. Aside from the few countries that link national or statewide immunisation registers to health data,12 evaluating the uptake of influenza vaccination in medically at‐risk groups is a global problem, with considerable gaps in monitoring coverage due to incomplete identification of these individuals. Requirement to report vaccines to the AIR Until recently, while strongly encouraged, there was no requirement to report vaccinations to the AIR except for pharmacists under legislation in NSW and the Australian Capital Territory.13 However, an amendment to the AIR Act has recently been legislated, making it mandatory for all vaccination providers to report to the AIR vaccines given under the NIP, through school‐based programs and privately, such as for seasonal influenza and vaccines required for travel purposes.14 Under the new legislation, coronavirus disease 2019 (COVID‐19) vaccines must be reported to the AIR. In addition, influenza vaccinations must be reported to the AIR from 1 March 2021 and all other NIP vaccinations must be reported from 1 July 2021.15 The requirement has ramifications, as the completeness of reporting is likely to be lower for vaccines recommended and funded as part of targeted programs on the NIP, previously limiting accurate coverage assessments. While no studies have examined completeness of reporting maternal vaccination to the AIR,6,7 this is exacerbated by incomplete adult vaccination data in the register, especially with the expansion of other vaccine providers, such as pharmacists and workplace programs.16 The COVID‐19 pandemic highlights the requirement for a more adaptable AIR. With more than 200 COVID‐19 vaccine candidates in development,17 the rollout of COVID‐19 vaccines will be complex due to expected availability and the delivery capacity of immunisation providers. With a need to protect the most vulnerable people first, Australia’s COVID‐19 vaccination program will prioritise border and quarantine staff, health care workers and medically at‐risk groups. These vaccination encounters will need to be recorded and tracked, both for coverage and vaccine safety, using active surveillance systems such as AusVaxSafety (www.ausvaxsafety.org.au). Potential solutions to improve vaccine uptake and tracking Improving vaccine uptake in targeted programs requires a multifaceted approach, such as education, reduction of access barriers, and key structural modifications that should focus on core capabilities of the AIR and reporting requirements. While recent NIP changes present a unique opportunity to redefine the core functions of the AIR, there are potential complexities and ethical considerations around reporting pregnancy and medical conditions to the register. One potential solution would be to consider the linkage of AIR data to other national datasets (eg, Medicare, the Pharmaceutical Benefits Scheme, hospitalisations, the Therapeutic Goods Administration adverse event database), as occurs in some other countries.12 This is relevant for the introduction of COVID‐19 vaccines, for which safety monitoring and coverage tracking will be critical. Another solution would be to include pregnancy and medical risk factor data fields in the AIR. This information could be entered directly by providers if reporting on the AIR secure website or reported in a semi‐automated manner via practice management software (PMS), which is how most reporting currently occurs. While pregnancy and medical risk factors are often recorded in PMS, ensuring this is done routinely and updated appropriately would require substantial provider education. To improve access and ensure better integration within immunisation provider settings, particularly in general practice, bidirectional capacity could be developed to enable the AIR to link with PMS to reconcile vaccination status and provide clinical decision support on catch‐up vaccination schedules. The stricter reporting requirements, such as mandated reporting of all vaccinations and linking NIP vaccines with reporting, as outlined in the recent Australian Immunisation Register Amendment (Reporting) Bill 2020,14 will be beneficial, although the implementation and ensuring compliance may be challenging. Under the new AIR Reporting Bill, in addition to education and support, non‐compliant providers may also be subject to financial penalties. However, an incentives approach to reporting, in addition to mandated reporting, could also be implemented. For example, general practitioners and other immunisation providers could receive administrative payments for reporting vaccinations to the AIR (similar to what is done with the NIP childhood vaccines), thus acknowledging the time it takes from their busy schedule. Despite the AIR being internationally recognised and celebrated within Australia, there is opportunity for improvement if the AIR is to fulfil its potential as a lifelong register. The most pressing challenges ahead are the need to continue to optimise reporting to the AIR and build capacity to identify special risk groups (particularly given the new targeted NIP programs), and the need to improve reporting of all non‐NIP vaccines. We welcome the recent AIR Reporting Bill 2020; however, there remains a particularly urgent need to have the ability to identify individuals with risk factors such as pregnancy or medically at‐risk status. This would not only use the full potential of the AIR and optimise vaccine coverage surveillance but would also offer benefits at the individual level. We appreciate that such changes to the AIR and provider practice may be cumbersome. However, we are seeking support from the broader medical community to raise awareness and advocate that these changes should be prioritised, not only to improve accuracy in recording of vaccinations and at‐risk status but also to facilitate providers’ ability to access AIR data for better patient care. NIP vaccine programs tailored to the increased risk experienced by population groups are important, such as those targeted to pregnant women or medically at‐risk individuals. We must ensure that we have the mechanisms to accurately assess coverage in these vulnerable groups, not just the routine childhood NIP‐funded groups, to drive optimal uptake and best practice.

Jane Tuckerman · Christopher C Blyth · Frank H Beard · Margie H Danchin

Careful planning is required to deliver a safe and effective COVID‐19 program Providing a safe and effective coronavirus disease 2019 (COVID‐19) vaccination program is required to mitigate against the current and future negative impacts on the health and wellbeing of all Australians from COVID‐19. An effective vaccination program is a key element required to facilitate economic recovery, safe movement throughout and beyond Australia and a return to the quality of life previously experienced. Development of COVID‐19 vaccines has progressed with incredible speed. Results of phase 3 studies were released in December,1,2,3 11 months after the pandemic was identified. Progress towards a COVID‐19 vaccine program has occurred at pace. Developing a COVID‐19 vaccine program With over 60 candidates in clinical trials, unprecedented efforts are driving vaccine development. Numerous approaches to vaccine design have been utilised, including traditional (inactivated, live attenuated, protein subunit) and more novel approaches (viral vector, nucleic acid). COVID‐19 vaccination program development and registration have progressed in Australia through well established existing pathways and partnerships. The National Immunisation Program was established by the Commonwealth, state and territory governments in 1997 to provide funded vaccines to the Australian population. Partnerships that underpin this program are being used to develop the COVID‐19 vaccination program. Vaccines are assessed through the national therapeutics regulator, the Therapeutic Goods Administration (TGA), which assesses safety, quality and efficacy, with advice from an independent body of experts, the Advisory Committee on Vaccines (Box). The Australian Technical Advisory Group on Immunisation (ATAGI) provides technical and clinical advice on the role of vaccines on the National Immunisation Program and oversees development of the Australian Immunisation Handbook. These existing organisations and committees are being utilised for developing the COVID‐19 vaccine program. Funding of vaccines on the National Immunisation Program usually requires submission to the Pharmaceutical Benefits Advisory Committee. If it is deemed cost‐effective, the Pharmaceutical Benefit Advisory Committee provides a recommendation to government for funding. Given the need for rapid action, the Australian Government established the COVID‐19 Vaccine Taskforce. Potential vaccines are being assessed by government, with advice from the COVID‐19 Vaccine and Treatments for Australia – Science and Industry Technical Advisory Group.4 Ensuring rapid access to COVID‐19 vaccines, the Australian Government secured agreements with suppliers of four lead candidates. A commitment to provide free access to vaccine for all people in Australia has been made.5 Leading vaccine candidates Considering different modes of action and the need for a range of suppliers with international and local manufacturing potential, advanced purchase agreements were signed in 2020 for the University of Oxford–AstraZeneca ChAdOx‐1 nCoV‐19 (AZD1222) vaccine (a viral vector vaccine); the University of Queensland–CSL V451 and Novavax NCX‐CoV2373 vaccines (protein subunit vaccines); and the Pfizer–BioNTech BNT162b2 vaccine (an mRNA vaccine).6 Interim phase 3 results have been published for two of these vaccines. Following randomisation of > 43 000 individuals aged ≥ 16 years (predominantly in the United States) receiving two doses of BNT162b2 or placebo, a 95% reduction in symptomatic laboratory‐confirmed COVID‐19 was reported among vaccine recipients (95% credible interval, 90.3–97.6%).2 Over 23 000 individuals aged ≥ 18 years were randomised into studies conducted in the United Kingdom, Brazil and South Africa. Randomised individuals received two doses of either AZD1222 (albeit utilising different dosing schedules) or a meningococcal vaccine; a 70.4% (95.8% CI, 54.8–80.6%) reduction in symptomatic laboratory‐confirmed COVID‐19 was observed.3 Further results from these trials are anticipated in 2021. Results from a phase 3 study of NCX‐CoV2373 involving more than 15 000 enrolled individuals aged ≥ 18 years were provided (by media release) in January 2021. The first interim analyses reported vaccine efficacy against symptomatic COVID‐19 infection of 89.3% (95% CI, 75.2–95.4%).7 V451, which uses the human immunodeficiency virus (HIV) gp41 protein to maintain the severe acute respiratory syndrome coronavirus 2 spike protein in its pre‐fusion state, generated false positive HIV antibody test results in vaccine recipients in phase I trials. Given potential adverse impacts on the program and the need to modify HIV testing algorithms, further trials of this vaccine were abandoned, with CSL agreeing to increase local manufacturing of AZD1222.8 Of the leading contenders, Australia has secured access to 20 million doses of BNT162b2 and 3.8 million doses of internationally manufactured AZD1222, with CSL also committed to locally manufacture 50 million doses of the latter.7 Much of the global 2021 vaccine manufacturing capacity is tied to pre‐market purchasing commitments, with Australia a leader in terms of the number of courses available per capita and diversity of vaccines.9 In addition, the Australian Government has joined 188 countries in providing funding to the COVID‐19 Vaccines Global Access (COVAX) Facility,10 a key pillar of the World Health Organization (WHO) Access to COVID‐19 Tools Accelerator.11 This enables access to a range of additional candidates but also supports access to vaccines for low to middle income countries. A critical question is the relative efficacy and real‐world effectiveness of current vaccines being trialled. No comparative trials are underway. Despite differences in efficacy point estimates, differences in trial design and study populations preclude any conclusions about their relative impact. For Australians, successful phase 3 studies show that both BNT162b2 and AZD1222 are likely to be effective. Both vaccines are likely to have key roles in the Australian program. Encouraging results from other candidates, including NCX‐CoV2373, suggest that these vaccines may also play a role. Key steps Essential components of the national COVID‐19 vaccine strategy12 include: identifying and supporting research and development; building a diverse portfolio of investments and strengthening local manufacturing; fostering international partnerships to contribute to the global efforts; streamlining regulatory pathways13 and collaborating with international regulators; and working with the ATAGI COVID‐19 Working Group14 to develop a safe and effective vaccination program. Potential candidates have been reviewed in detail by the TGA and ATAGI, a process which will continue as further data emerge. Provisional determination by the TGA for potential vaccines enables preliminary data to be reviewed ahead of submission of the full regulatory dossier.13 Full review of lead candidates by the TGA led to approval of both Pfizer–BioNTech BNT162b2 and Oxford–AstraZeneca AZD1222. Ongoing review of other candidates continues. Advice on priority populations continues to be developed by ATAGI, initially focusing on population groups at greatest risk of exposure, severe outcomes and transmission, in addition to individuals critical to societal functioning such as emergency services, police and public health personnel.15 Key values (as outlined in the WHO Strategic Advisory Group of Experts on Immunisation values framework) including wellbeing, respect, equity, reciprocity and legitimacy have been considered in identifying priority populations.16 Prioritisation must be informed by both the epidemiology (with a focus on locations with current community COVID‐19 activity) and modelling to examine the impact of varying vaccine characteristics (relative effectiveness, duration of protection) and target populations on overall disease control. Health care and aged care workers have been identified as priority groups for early vaccination in all scenarios. In addition to sites of routine immunisation delivery, additional locations including dedicated vaccination clinics and workplace and in‐reach clinics will be required to ensure timely access for all.17 Chosen locations will need to consider logistic challenges including storage conditions (the Pfizer–BioNTech vaccine must be stored at − 60⁰C to − 90⁰C and used within 5 days of defrosting)18 and supply in multi‐vial trays containing multi‐use vials. Workforce development, training and resources (particularly in the safe use of different multi‐use vials) are critical components required for a safe and successful program. Current COVID‐19 vaccine trials include 30 000–50 000 participants, of whom roughly half will receive the vaccine. These large studies can detect common adverse events, but to pick up serious but very rare side effects, ongoing monitoring of vaccine safety will be required. Post‐marketing surveillance, underway in the Northern Hemisphere, will provide additional reassurance about the safety of these vaccines. A COVID‐19 pharmacovigilance plan, incorporating key vaccine safety programs developed since 2009 including AusVaxSafety (http://www.ausvaxsafety.org.au) and vaccine safety reporting programs established in states and territories, will ensure real‐time monitoring of adverse events. Critical to safety and effectiveness monitoring is use of the Australian Immunisation Register. Amendments to the Australian Immunisation Register legislation requiring mandatory reporting of all vaccines have been passed by Federal Parliament.19 Additional data systems to streamline reporting to the Australian Immunisation Register and provider education will be required to ensure all administered doses are captured. These changes will ensure all individuals have a valid, durable and reliable record of vaccination. This will assist program rollout (eg, being able to determine which brand a patient has previously received) and also help inform program evaluation (eg, by providing estimates of vaccine coverage at the population level). Provider and community confidence are paramount to program success.20 Ongoing research to explore the structural, social and behavioural factors that may compromise vaccine acceptance is required. Clear and regular communication with providers and the public by trusted scientific and public health sources about what is known, as well as uncertainties, is required. The development and dissemination of evidence‐based information, along with additional messages for specific target groups and support materials to assist health care providers in discussions with patients, continue to be prepared. A clear and realistic understanding of vaccine effectiveness and expected adverse events are required to combat an anticipated escalation in COVID‐19 vaccine misinformation. As we commence the COVID‐19 vaccination program, we enter a new phase of the Australian response to the pandemic. Although millions of influenza vaccines are distributed each year, the COVID‐19 immunisation program will be more complex than any other immunisation program in Australia’s history. Evidence‐informed public policy, collaboration between governments and between program administrators and providers, along with clear communication, are required to ensure programmatic success. Box – Key steps involved in routine and COVID‐19 immunisation programs Routine immunisation delivered by the National Immunisation Program COVID‐19 immunisation program Initiation of process Sponsor application to the TGA and PBAC Australian Government with advice from the SITAG Regulatory decisions TGA with advice from the ACV TGA with advice from the ACV Purchasing decisions Australian Government with advice from the PBAC Australian Government with advice from the SITAG Clinical and other technical information Statements from ATAGI with support from the NCIRS Multiple providers, including ATAGI statements, NCIRS fact sheets and training materials contracted by Australian Government Department of Health Program implementation Australian Government Department of Health in conjunction with jurisdictions Australian Government COVID‐19 Vaccine Taskforce and Department of Health in conjunction with jurisdictions ACV = Advisory Committee on Vaccines; ATAGI = Australian Technical Advisory Group on Immunisation; NCIRS = Immunisation Research and Surveillance; PBAC = Pharmaceutical Benefits Advisory Committee; SITAG = COVID‐19 Vaccines and Treatments for Australia – Science and Industry Technical Advisory Group; TGA = Therapeutic Goods Administration.

Christopher C Blyth · Katie L Flanagan · Robyn A Gibbs · Nigel W Crawford · Allen C Cheng

Challenges with data infrastructure are affecting medical workforce research and access to medical care Access to high quality medical care can save lives and help reduce the consequences of the growing burden of chronic disease. However, the delivery of this care relies on a well trained health and medical workforce organised to optimally respond to community need, working in supportive work environments within models of care that are fit for purpose, with minimal geographic or financial barriers to access for all communities. There has been a long term need in Australia for coordinated, evidence-informed workforce policies. However, for many years the development of the medical workforce has been shaped by self‐regulation and market forces. Short term and uncoordinated workforce planning has generated cycles of contraction and expansion of training places, sporadic regulation, and recent policy dilemmas.1,2 Most recently, a dramatic increase in numbers of graduates from Australian medical schools has occurred in the absence of clear plans as to how to use these additional doctors to optimally meet community need. Early data suggest that flooding the market with more graduates has not addressed persistent rural shortages, with insufficient numbers willing or able to navigate a career pathway to work in areas of need.3,4 Oversupply continues to be an issue in some specialties (eg, emergency medicine or cardiothoracic surgery) while shortages persist in others such as general practice and psychiatry.5 Over‐reliance on international medical graduates continues in many rural communities,1 while the fierce competition for accredited training places in some specialties leaves many junior doctors caught in the middle.6 Furthermore, Australian doctors are increasingly reporting burnout and mental health problems,7 with significant negative effects on productivity and patient safety.8 With these problems seeming to defy solutions,9 it is not surprising that there have been calls to add the work–life balance of clinicians to the Institute for Healthcare Improvement’s set of principles to guide optimising health system performance (optimal patient experience, improved population health and reducing costs).10 In light of these issues, the development of Australia’s new National Medical Workforce Strategy (NMWS) scoping framework and consultation process for the final strategy is welcome. The NMWS is being designed to frame the development and coordination of national medical workforce policies to address our pervasive workforce challenges: geographic maldistribution; specialty over‐ and undersupply; the balance of generalists and specialists; Indigenous and culturally safe workplaces; doctor work readiness; and changing models of care.11 One of the six principles of the NMWS is to “[a]pply an evidence‐based approach wherever possible, drawing on data and information from all stakeholders”.11 Data on the medical workforce Achieving an evidence‐based approach to workforce policy requires more high quality longitudinal and linkable data that is both broad across different doctor groups and rich in doctor characteristics, compared with what is currently available (Box). Institutional bias, fragmentation, inconsistent definitions and restricted access provide substantial barriers to our ability to use those data for the social good. Few available sources offer a long term, holistic and objective view of the medical workforce: professional training bodies can only use data sourced from relatively brief periods of postgraduate training; the Department of Health relies on Medicare billing data and raw counts of medical practitioners through the Australian Health Practitioner Regulation Agency; and the states are limited to poor data on salaried, generally hospital‐based practitioners. Data that are made available to researchers are overly aggregated, especially geographically, often preventing useful evidence from emerging about medical workforce behaviours, training outcomes, career choices and treatment patterns. Many sources remain closely guarded by training and service providers and governments, such as surveys regularly completed by doctors on registration with the Australian Health Practitioner Regulation Agency (including the new national medical training survey12) or with individual colleges. Where data are controlled by individual agencies, there is minimal potential for multipurpose use and no process for linkage to other sources. Hence, it is impossible to understand and track career pathways of doctors even though these are a key element of policy. The analysis of workforce data to generate evidence from these multiple sources has been relatively unsophisticated and preoccupied with the simple modelling of supply and demand — ignoring how practitioner behaviours, and the drivers of those behaviours, influence workforce numbers and practitioner quality. Although these data can be used to count and describe trends, they mostly cannot be used to understand why decisions are being made and how services are driven, which are essential for designing policy. The Australian community deserves a broader understanding as to how different policies and programs are addressing their needs. Lack of this understanding has been a major contributor to the decisions that have led to the current situation of workforce oversupply.16 Neither are health workforce data linked to patient‐level data — a factor overlooked in the NMWS scoping framework — that is, data on inputs are not linked to data on activities, outputs and health outcomes, making it impossible to determine how workforce and policy changes affect community needs and population health. Any policies aimed at the medical workforce should at least examine their effects on patients. Finally, the availability of administrative medical workforce data to researchers is at an all‐time low. There was a reduction in funding of the Medical Schools Outcomes Database in 2015 and the withdrawal of funding (from 2016) for the Australian Institute of Health and Welfare to produce health workforce statistics. The Bettering the Evaluation and Care of Health (BEACH) study14 was also discontinued as the only data on the clinical activities of general practitioners. Adding to the challenge, the internationally unique Medicine in Australia: Balancing Employment and Life (MABEL) panel survey of 9–10 000 doctors per year ceased in 2019 after 11 annual waves of data collection.13 Moreover, researchers skilled in using health workforce data will be difficult to sustain without addressing the availability of data, and this expertise will soon dissipate, adding to severe reductions of health workforce analytical staff at the Commonwealth level when Health Workforce Australia ceased in 2014. It is notable that the new National Health Information Strategy makes no mention of health workforce data.17 Despite its ongoing reliance on competitive grant funding, MABEL data have played a key role in national medical workforce policy over the past 11 years. It was a World Bank exemplar of health workforce data collection internationally,18 and continues to guide the distribution of over $1 billion funding to regional health care through its use in the design of the Modified Monash Model (used to classify which geographical areas are eligible to receive increased funding), as well as supporting the design of rural health workforce programs. Unlike other datasets (Box), MABEL data transcended traditional divides of salaried and private practice, different doctor types, career stages and career trajectories as the basis for supporting policy and program decision making at a national scale. The future for medical workforce research The medical workforce represents the backbone of the health care system and a major public investment, yet despite the large gap between supply and community need, the scope of available data does not support evidence-informed decision making. While existing administrative and registration minimum data support national medical workforce planning, they are unable to give insights into doctors’ career and clinical decisions. With the pressures on the health care system and medical workforce at an all‐time high, we believe that the Australian community deserves better insights into how different medical workforce policies and programs are promoting access to equitable, high quality care. We need to know more about the doctors being produced from long and expensive taxpayer‐funded training programs, as well as why they choose disciplines, practice locations and practice patterns. Moreover, there is a growing awareness of the importance of maintaining the health and wellbeing of this workforce, but available national data to underpin key policies to prevent poor mental health are missing. We propose that any reforms to the Australian health care workforce must be informed by robust evidence. The collection and availability of this evidence needs to be at the forefront of policy and planning, embedded within objectives of key national strategies such as the NMWS and National Health Information Strategy. Future medical workforce data strategies need to be institutionally neutral, guided by a research strategy including agreed priority research questions with resources to conduct the research, and underpinned by openness and data sharing. Healthy national medical workforce data are fundamental to achieving healthy doctors and communities. Box – Available national datasets on the medical workforce* table#t1 tbody td:nth-child(n+2) P. Pleft { text-align: center; } Data source Unit record data available to external researchers Unique identifier to enable linkage over time Data linked to patients Rich data on doctor characteristics Doctors grouped by organisation (practice, hospital) Doctor group Medicare provider file/MBS With consent Yes Yes No No Private practice Medical college surveys No Yes (but some surveys anonymous) No No No Vocational trainees and Fellows National medical training survey12 No No (anonymous) No No No Pre‐vocational and vocational MABEL13 With consent Yes No Yes Yes All medical practitioners BEACH14 No NA (random sample of GPs each year) Yes Yes Yes GPs National Health Workforce Dataset15 AHPRA registration data No Yes No No No All medical practitioners AHPRA registration survey No (table builder available) No No No No All medical practitioners Medical Education and Training dataset No No No No No Pre‐vocational and vocational BEACH = Bettering the Evaluation and Care of Health; GP = general practitioner; MABEL = Medicine in Australia: Balancing Employment and Life; MBS = Medicare Benefits Schedule; NA = not applicable. * States and territories also have their own data collections for the public hospital workforce, but these vary in what is collected and are not available to external researchers. Many hospitals in recent years also conduct surveys of health and wellbeing. Many clinical registries, epidemiological datasets, hospital separation data, and electronic medical record data focus on patients and do not include doctor identifiers or characteristics.

Grant M Russell · Matthew R McGrail · Belinda O’Sullivan · Anthony Scott

The current mechanism for setting air quality thresholds in Australia does not adequately protect community health The current air quality framework to mitigate against the health effects of exposure to air pollution within Australia relies on national environmental protection standards — set out under the National Environmental Protection (Ambient Air Quality) Measure (the ambient air quality NEPM) — and the jurisdictional requirements for monitoring and reporting exceedances.1,2 The ambient air quality NEPM sets reportable limits for key criteria air pollutants.1 Criteria air pollutants are those that are legislated internationally as measures of air quality and include particulate matter (PM), nitrogen dioxide (NO2), carbon monoxide, ozone, sulfur dioxide (SO2) and lead1 (Box). Air toxics are non‐criteria air pollutants that are considered to pose a hazard to human health.7 Air toxics are legislated under a separate NEPM which has the goal of generating baseline data for later development of standards for five compounds: benzene, benzo(a)pyrene, formaldehyde, toluene and xylenes.7 The air toxics standards, based on the gathered baseline data, were due to be set in 20127 but are yet to be reviewed. In 2011, the National Environment Protection Council published guidelines for setting air quality standards.8 These guidelines outline a method that balances risk assessment (health effects based on the exposure–response relationship) with the costs of abatement strategies to achieve the required targets. The process for updating the ambient air quality NEPM based on new evidence about the health effects of criteria air pollutants is slow. Since the publication of these guidelines,8 there has only been one formal change to the NEPM, which was approved in 2016.1 This variation focused on modifications to the measures related to PM10 and PM2.5 (PM ≤ 10 µm and ≤ 2.5 µm in aerodynamic diameter, respectively), as it was thought that the potential benefits to human health, and the available abatement strategies, were greater than those for other criteria pollutants.9 The variation included, among other measures, the introduction of an annual average for PM10 and progress towards the introduction of a PM2.5 standard. The national standards for gaseous pollutants are currently under review.10 Moreover, the catastrophic 2019–20 bushfires have highlighted the importance of air quality for many Australians. It is therefore timely to consider the current ambient air quality standards and whether they are fit for purpose. We focus on the criteria air pollutants as these are the only air pollutants currently covered by legislation that attempts to enforce maximum exposure limits. Criteria air pollutants — are there safe limits? Particulate pollutants Air pollution is composed of a complex mixture of solid, liquid and gaseous molecules. Airborne PM is comprised of solid and liquid particles suspended in the air that vary in size and chemical composition. PM is generated from a range of sources including combustion, plant materials, sea salt and earth‐derived inorganic compounds. PM10 is small enough to bypass the upper airways and lodge in the conducting airways, but is usually too large to reach the alveoli. Acute exposure to PM10 is associated with hospitalisations and mortality for cardiorespiratory conditions,11 while long term exposure is linked to chronic cardiorespiratory conditions and metabolic disorders.12 No safe threshold for PM10 exposure has been identified.5,6 PM2.5 can penetrate deeper into the lungs and is one of the leading causes of global mortality and morbidity.13 PM2.5 has been linked to cardiovascular disease, respiratory disease, pre‐term birth, metabolic disorders and neurological health problems.4 Like PM10, there is no evidence for a safe threshold for PM2.5 exposure. This has been highlighted in Australian studies, where PM2.5 is typically low, showing associations between exposure to PM2.5 and mortality.2 Consistent with this, there is evidence that the exposure–response relationship is steeper at lower PM2.5 concentrations.14 Gaseous pollutants Of the gaseous air pollutants, data are most extensive for NO2, a combustion by‐product. Studies on the health effects of low concentrations of NO2 have shown associations between NO2 and childhood pneumonia and otitis media15 and impaired lung function.16 While data on the exposure–response relationship suggest that there is an effect threshold,2 it is three to five times lower than the current NO2 standard (Box).1 Data on the magnitude of the health effects of SO2, a combustion product primarily related to sulfur‐containing fuels, are less extensive. While there is an established relationship between exposure to SO2 and cardiorespiratory mortality,3 data are not robust enough to determine whether there is a health effect threshold. Similarly, while carbon monoxide has a range of physiological effects on the body,17 the co‐existence of carbon monoxide with other criteria pollutants makes it difficult to disentangle the contribution of this pollutant to the health effects of pollution in general. Acute exposure to ozone, a by‐product of interactions between combustion emissions and sunlight, is strongly linked to respiratory hospitalisations; however, consensus regarding a threshold for these health effects is contentious.18 Lead pollutants The teratogenic and neurological health effects of lead are well established and there is no safe level of exposure.4 While overall community exposure to lead has decreased with the elimination of tetraethyl lead from fuels, there are still some communities in Australia exposed to anthropogenic sources of lead. Summary Collectively, there is sufficient evidence to conclude that there is no safe threshold for exposure to PM10, PM2.5 or lead. For NO2, there is a threshold, but the current NEPM standard is well above this level.1 On this basis, the current standards are not sufficient to adequately protect the health of the Australian community (Box). Principles for setting air quality guidelines in Australia In Australia, the background concentrations of air pollution in most areas are relatively low compared with other countries around the world.19 To a certain extent, it is likely that this observation influences current policies regarding ambient air quality standard setting, which aim to identify a threshold concentration where the health risks are balanced against the feasibility of achieving these thresholds. Unfortunately, this puts regulators in a position of balancing the costs of expanding infrastructure against the benefits to human health, as the existing monitoring network, which assesses adherence to the standards, does not have sufficient coverage to generate data with enough accuracy to monitor exceedances.20 The adverse health effects of the NEPM criteria pollutants are well established. For many (eg, PM2.5), there is sufficient evidence, both from our review and expert consensus, that it is not possible to set a threshold as health effects can be detected even at low exposure doses, whereas for others, the threshold is well below the current NEPM standard (eg, NO2). The current approach to regulation of air pollution implies a causal model that is inconsistent with the available evidence. It provides no incentive for reducing exposure and allows increases in exposure to harmful pollutants, as long as the levels remain below the thresholds. This provides only partial health protection and adversely impacts community perceptions by implying that the current standards represent a “safe” level of exposure. It also relies on an accurate and comprehensive network for monitoring exceedances, which is lacking in many Australian jurisdictions, and appropriate mechanisms to ensure implementation of the measures, including appropriate penalties if standards are not met. We believe this approach must be replaced by regulation focused on harm minimisation using the principle of continual improvement; similar to the approach recently adopted by the European Union where targets for PM2.5 are set for percentage reductions in levels within a given time frame.21 This would drive better practice in air quality management and encourage implementation of strategies that improve ambient air quality and health for all Australians by reducing existing levels of exposure and discouraging new increases in exposure, regardless of the current levels. The concept of “no safe limit” was raised in independent commissioned reports20,22 provided before the most recent NEPM variation23 to guide the decision‐making process. The concept of an exposure reduction framework was also raised at that time and included in the impact statement prepared for the National Environment Protection Council outlining the case for the NEPM variation.9 It was argued that the introduction of an exposure reduction framework was necessary because there was no evidence for a threshold for the health effects of exposure to PM and, in contrast to the existing NEPM approach, it would maximise the community level health benefits.20 Unfortunately, it seems that this approach was dismissed because of concerns regarding the ability to monitor overall reductions in PM, due to inadequate monitoring infrastructure across the country, and whether reductions could actually be achieved.23 This seems to ignore the intent of such a framework — it is not about setting targets, it is about driving behaviour and promoting best practice. Reassuringly, the most recent impact statement prepared for the National Environment Protection Council for the revision of the standards for gaseous pollutants24 recommends changing the NEPM to make reference to minimising the health effects of exposures and “incorporation of exposure–reduction targets”. We endorse this approach. However, the recommended measures for gaseous pollutants still seem to rely on specifying a standard in the future,25 albeit a lower one, as part of an exposure–reduction framework, rather than proposing goals for continual reduction. In the absence of a mechanism to promote continual improvement and best practice by regulators and industry, we are failing to adequately protect the Australian community from the health impacts of air pollution. Box – Current National Environmental Protection Measures (NEPMs) for criteria air pollutants,1 the current evidence for the dose threshold for detectable health effects in humans, and whether the NEPMs are above these thresholds Pollutant Average maximum concentration Measurement period Allowable exceedances Dose threshold for health effects NEPM above health effect threshold Carbon monoxide 9 ppm 8 hours 1 day/year Unknown NA Nitrogen dioxide 0.12 ppm 1 hour 1 day/year Unknown NA 0.03 ppm 1 year None ~ 6–11 ppb2 Yes Ozone 0.10 ppm 1 hour 1 day/year Unknown NA 0.08 ppm 4 hours 1 day/year Unknown NA Sulfur dioxide 0.20 ppm 1 hour 1 day/year 0.2–0.4 ppm3 No 0.08 ppm 1 day 1 day/year Unknown NA 0.02 ppm 1 year None Unknown NA Lead 0.5 µg/m3 1 year None None4 Yes PM10 50 µg/m3 1 day None None5,6 Yes 25 µg/m3 1 year None None5,6 Yes PM2.5 25 µg/m3 1 day None None2 Yes 8 µg/m3 1 year None None2 Yes NA = not applicable; PM10 and PM2.5 = particulate matter ≤ 10 µm and ≤ 2.5 µm in aerodynamic diameter, respectively.

Graeme R Zosky · Stephen Vander Hoorn · Michael J Abramson · Sophie Dwyer · Donna Green · Jane Heyworth · Bin B Jalaludin · Jennifer McCrindle-Fuchs · Rachel Tham · Guy B Marks

Careful planning is required to ensure new resources for mental health lead to better consumer care Both the Productivity Commission into Mental Health1 and the Royal Commission into Victoria’s Mental Health System (RCVMHS)2 acknowledge that mental health services have been in the grip of a protracted resourcing drought. The RCVMHS identified that, until recently, Victoria’s public mental health services have fared particularly badly,3 with the 2015–2016 per capita funding to public mental health services being the lowest of any state. The impacts of chronic under‐resourcing, including a predominant focus on managing risk, underutilisation of evidence‐based therapies, and a lack of individualised care, were all reported by service users in testimonies highlighted in the RCVMHS interim report.2 After years of stagnation, in 2020 Victorian mental health services experienced some funding growth.4 These resources have allowed our team to strengthen existing services; bring on new staff, including expanding our lived experience workforce; and initiate new programs, including the Hospital Outreach Post‐Suicidal Engagement (HOPE) initiative, intensive community packages of care, the pre‐hospital response of mental health and paramedic team (PROMPT), and a mental health, alcohol and other drugs hub in our emergency department. In addition, our service is currently planning new mental health beds and rolling out an innovative hospital‐in‐the‐home program stemming from the recommendations of the RCVMHS interim report. We anticipate the final recommendations, due in February 2021, will bring even more new resources. Like sudden heavy rain on degraded soils after drought, such an inundation is welcome, but not without its own risks and challenges. Our recent implementation efforts have highlighted several challenges in managing rapid funding growth, including issues with human resources, leadership capacity, change management competency and stakeholder engagement, which will need consideration across the system to ensure services can translate funding into better consumer care. Human resources Delivering care requires staff who are difficult to find. There are insufficient mental health nurses5 and psychiatrists6 to fill current roles, particularly in regional and rural areas, and with an ageing workforce,7 problems with staffing are predicted to worsen.6 While international recruitment may assist, these processes come with lengthy delays and high administrative burdens. As a consequence, program implementation may be delayed due to recruitment challenges, or may adversely affect the operations of other service areas when clinicians shift between roles. Significant investment in training and recruitment pathways are required to prevent workforce shortages becoming a barrier to the pace of reform. Diversification of disciplines, grades and programs that encourage qualified staff to enter mental health care will all be required.1 Leadership capacity and competency in change management The presence of effective leadership and competency in change management principles are critical for successful health reform.8,9 Rapid growth can stretch existing leadership capacity. Health leaders already face significant challenges at system (eg, demographic changes, increasing demands, advancing technology), organisational (eg, human resources, changes to organisational structures and processes, intensification of frontline and middle management roles) and individual levels (eg, lack of role clarity, lack of training in managerial and leadership capabilities).10 For leaders already managing the challenge of daily operations, additional responsibilities to enact significant reform quickly carries a risk of overload. A key potential outcome of overload is loss of focus on the consumer.11 Therefore, as the pace of desired reform increases, a focus on developing current and future mental health leaders should be prioritised.2,12 Engaging stakeholders meaningfully Meaningful stakeholder engagement is crucial to successful change.9 As outlined by the RCVMHS, the “necessary changes to the mental health system cannot … be achieved by government alone”.2 The implementation of new programs requires engagement with diverse stakeholders including consumers, carers, staff, hospital executives, government and industrial bodies. Such stakeholders often have different interests, and forging and maintaining alignment is critical to progress. Meaningful engagement is vital to achieving this and subsequent success,9 but it is also resource intensive. Enacting multiple reforms quickly carries the risk that meaningful stakeholder engagement may be sacrificed. For this reason, timelines for delivery need to balance urgency with getting things right. The appropriate urgency for implementation articulated in the initial recommendations from the RCVMHS (eg, operation of an additional 170 acute mental health beds by mid‐2022) will only be achieved if those leading the change are supported and those affected by the change are included. Harnessing a generational opportunity for reform The RCVMHS calls for transformational change2 to our mental health system. The pace of this change and the other challenges involved must be managed carefully by system leaders to ensure that the intended reform occurs and results in provision of better care to the community.

Steven Moylan

A 74-year-old Vietnamese man presented with a 1-year history of pruritic nodules on his feet

Kajal Patel · Alexander Gin · Laura Scardamaglia

Should medically significant genetic results be offered to research participants or their at‐risk relatives? Australian research studies now generate genetic information on thousands of participants. Some genetic results, present in a small portion of participants (< 5%), are considered medically actionable, meaning they are associated with increased risk of adult‐onset diseases, where effective risk management, prevention or treatment exists (eg, inherited cancer or cardiac disorders).1 The National Statement on Ethical Conduct in Human Research,2 which considers genomic research at Chapter 3.3, now requires an ethically defensible plan for return (or non‐return) of genetic research results. Box 1 summarises the guidelines that are relevant to the return of genetic results to research participants.2 Returning genetic research results can be life‐saving, alerting participants to preventive steps that they would not otherwise have taken. Most participants identified in research studies have no clinical features or family history of the indicated disease, are unaware of their genetic risk, and would not qualify for publicly funded clinical criteria‐based genetic testing. Among the international genomics community, there is growing consensus that medically actionable genetic research results should be made available to participants.3 The American College of Medical Genetics and Genomics published a list of genes related to medically actionable conditions, in which results should be returned if identified during clinical testing.1 This gene list has been used to guide the return of research results in some United States studies,4 but has not been adopted by the National Health and Medical Research Council or other Australian bodies. However, the National Statement makes it clear at 3.3.41 that “researchers have an obligation to have a process in place for the return of findings that are of proven validity and of health significance to the participant, or relative, subject to participant consent”.2 However, even where participant consent has been obtained, not all Australian studies are returning medically actionable results, due to varying ethical and practical challenges. For example, research participants may provide samples for altruistic reasons, before research analysis, without expectation of re‐contact. Should results be returned to these individuals, especially those unaffected by indicated disease? Is there a legal or ethical requirement to make results available or liability for withholding them? The National Statement provides some guidance (Chapter 3.3) regarding which results should be returned,2 but ultimately researchers determine whether to return results. As the National Statement indicates, return of results should be limited to those genes with validity and utility (3.3.29 and 3.3.41).2 However, pathogenic variants in medically actionable genes are not fully penetrant, meaning that not all at‐risk variant carriers develop the disease.5 Risk estimates for many genes are still uncertain, complicating decisions around medical actionability and the time frame for returning results. Some participants may experience surprise or distress on learning about genetic risks. Returning results may also raise the possibility of out‐of‐pocket medical costs or increased insurance liabilities for younger participants. Genetic results should be delivered by a medical professional, with genetic counselling and clinical support provided, as noted by the National Statement (3.3.31 and 3.3.32).2 This requires time and resources, which are often limited. Thus, despite clear guidance in the National Statement, some research studies do not return results even where results are clinically valid and of undisputed relevance to participants’ and family members’ health, and the participant has consented to receive such results. To assist with these challenges, a national service to support the return of genetic results from research studies has recently been developed6 and is now operational. Research cohort case studies Here, we present two case studies from Australian epidemiological research (Box 2). Lifepool,7 a large community‐based study of women in the general population, and ASPREE (ASPirin in Reducing Events in the Elderly),8 a large cohort study of healthy older people, have both commenced genetic analysis and have been faced with decisions regarding the return of genetic results. These case studies highlight the challenges and opportunities related to this complex issue. ASPREE's older population particularly raises unique challenges.9 Lifepool has shown that return of genetic results prompts preventive interventions for women with variants in high risk breast cancer genes, most of whom would not have been identified through current clinical criteria‐based testing.7 To date, Lifepool has contacted 73 women previously unaware of their high risk variants. None of the women identified with a cancer‐causing variant would have been eligible for publicly funded testing through the Australian clinical system. Most women took proactive steps to mitigate risk after receiving genetic results. Of the 73 women, 23 so far have undergone risk‐reducing surgery (bilateral oophorectomy), mitigating their cancer risk.11 This could be life‐saving, given the high lifetime risk and low survival rates for ovarian cancer associated with high risk variants. The shared nature of DNA means genetic results are also relevant to participants’ blood relatives. Beyond participants who directly received results, 63 relatives were also tested through cascade testing, 32 of whom were also found to have a high risk variant. These relatives were, on average, substantially younger than the original participants (Box 3), making this information even more valuable for prevention. ASPREE biobank participants consented to re‐contact regarding genetic results relevant to personal or family health. In accordance with the National Statement (3.3.36 and 3.3.37),2 an ethically defensible plan outlining the return of genetic results was approved by the Alfred Hospital Human Research Ethics Committee in 2015.9 However, there is ongoing debate about the most appropriate strategy, given the age of the cohort (average, 75 years) and primary purpose of the study — an aspirin prevention trial (as opposed to genetic research study). ASPREE has returned other types of (non‐genetic) medically actionable research results, including abnormal magnetic resonance imaging, blood pathology and cognitive assessments. However, genetic results have been treated differently, with unique challenges. Many older ASPREE participants who carry medically actionable variants have seemingly outlived their increased risk, displaying no signs of indicated disease at 75 years of age and older.12 Is the information still medically actionable? Do participants still want to know? Should results be returned for the benefit of younger, potentially high risk family members? What about ASPREE participants who are in cognitive decline or deceased? Is ASPREE obliged to contact these individuals, or their relatives, to provide genetic results? Despite having detected genetic information through research analysis that is clinically valid and of clear relevance to personal or family members’ health, ASPREE has not yet commenced returning genetic results, seeking to achieve an appropriate harm–benefit balance.9 The applicable Human Research Ethics Committee recently discussed a possible strategy of offering results via an opt‐in model, where participants register interest following a newsletter notification. Although well intended, this approach is problematic. First, only a fraction of participants would receive or read the newsletter article, limiting the number who would be informed. Second, only about 1% of the cohort will have a medically actionable variant, meaning the likelihood that those participants will have opted‐in is very small. Finally, ASPREE participants have already consented to re‐contact on the basis of medically actionable genetic results, so re‐consent is not required. The proposed opt‐in model compromises equity in ensuring high risk participants are contacted and offered results ethically. The consequences of a passive approach to returning results are notable. For example, two male ASPREE participants were found through the study analysis to have high risk breast cancer variants. Neither participant had any relevant personal cancer history. Analysis of collected family history data showed that both had daughters (who have a 50% chance of having the same pathogenic variant) who developed breast cancer under the age of 50 during the ASPREE trial. These women did not have a family history of breast cancer required to prompt clinical genetic testing through clinical services. Yet their fathers’ results, if known, may have prompted genetic testing or high risk breast cancer screening for the daughters. This information was clinically significant and relevant to family health, despite its questionable health benefit to the male participants. Although the time for prevention has passed for those participants’ daughters, ASPREE must now consider the return of results to other participants with medically actionable results. Currently, there is no Australian legal requirement to inform research participants of medically actionable genetic results — any imperative to offer results is ethical. Whether any ethical imperative extends to preventing disease in participants’ relatives is unclear,13 although it is contemplated by the National Statement (3.3.32 and 3.3.41).2 A concern arising when considering return of results in ASPREE is that elderly research participants may not want to know about genetic results. However, other studies suggest that most research participants do want to receive genetic information, even if only for their family members’ benefit.14,15 A recent international survey on preferences for genetic results14 showed no significant difference between elderly and younger groups. Evidence suggests that older participants may be more interested in genetic results, especially if family members may benefit.14 Another challenge arises where participants with medically actionable genetic results are deceased or in cognitive decline. In these circumstances, the benefit of returning results to next‐of‐kin is for relatives. Several Australian research studies return genetic results purely for family members’ benefit, demonstrating the acceptability of this approach. The Australian Ovarian Cancer Study commenced returning genetic results of deceased women to next‐of‐kin more than ten years ago.16 Recently, the TRACEBACK study archived DNA samples of women who died from ovarian cancer, to identify genetic risk variants and notify at‐risk relatives.17 These programs conduct genetic testing on DNA of deceased people who cannot derive personal benefit, for the benefit of at‐risk relatives. Conclusion There is a growing consensus on the ethical imperative to offer research participants medically actionable genetic results. Studies show high acceptability for receiving genetic results, and the preventive health benefits are clear. Although the National Statement provides guidance, questions remain regarding the legal obligations and disclosure methods, particularly when research participants lack the capacity to make decisions about receiving genetic information. As genetic information becomes more pervasive and valuable to preventive medicine, the return of medically actionable genetic results will become increasingly important from ethical, legal and medical perspectives. Box 1 – National Statement on Ethical Conduct in Human Research: guidelines relevant to return of genetic results2 Guideline Content 3.3.26 In considering whether to return results of research, researchers should distinguish between individual research results and overall research results. Researchers should consider how these results will be provided to participants, how the process of returning results will be managed, and the risks of the return of individual research results and overall research results. 3.3.27 Return of findings and results relating to an individual participant depends on the contextual relevance of the findings; some genomic research findings must be returned, some findings may be returned, and some findings should not be returned. 3.3.29 Once there is sufficient evidence and agreement that a finding or result is clinically significant, participants should be advised that research results or findings that may be returned will first need to be confirmed according to applicable guidelines; eg, at a National Association of Testing Authorities accredited laboratory. 3.3.31 Any plan to return individual research results should include linkage with a clinical service and access to genetic counselling. The plan should specify any expertise to which the project team might require access. 3.3.32 The return of results or findings of significance for the health of the participant or relative is the responsibility of the appropriate clinical service or, where such a service is not available, the participant's clinician in consultation with the research team. 3.3.36 Researchers must prepare and follow an ethically defensible plan to manage the disclosure or non‐disclosure of genomic information of potential importance for the health of research participants or their relatives. 3.3.37 The ethically defensible plan must be approved by a Human Research Ethics Committee. Step 1: Determination of whether findings will be returned Genomic research falls into three categories: research with findings that must be returned; research with findings that may be returned; and research with findings that should not be returned. The relevant factors to be considered to determine whether findings must, may or should not be returned include: analytic (scientific) and clinical validity; significance to the health of the participants/relatives; and clinical utility. 3.3.41 Where there will be any return of findings to participants, they should be advised as to which findings will be returned and which will not be returned, as follows: that researchers have an obligation to have a process in place for the return of findings that are of proven validity and of health significance to the participant or relative, subject to participant consent; that if researchers plan to return findings during the project that are of proven validity but are not of health significance to the participant or relative, they will need to justify this plan; that there is no obligation on researchers to look at or assess findings outside of the scope of the research; and that there is no ongoing responsibility on researchers to review findings of a research project after the project has been completed in order to discover or assess findings that may have become returnable due to later scientific advances. Box 2 – Research cohort case studies Lifepool study7 ASPREE study8 Australian study aiming to improve women's health, particularly with respect to breast cancer Randomised, placebo‐controlled Australian trial for daily low‐dose aspirin, and ongoing observational cohort study of ageing Participants 50 000 women 19 000 healthy older men and women aged > 70 years Consent for genetic testing and return of results DNA samples were contributed to a “pool” of data and consent given for unspecified future research Participants were informed they would be contacted if information relevant to their health was found DNA samples were contributed to a biobank with consent for future genetic research Participants were informed they may be contacted if information relevant to their health was found An ethically defensible plan for re‐contacting participants with medically actionable results was approved by the applicable HREC9 Genetic testing conducted 14 799 samples were tested for changes in high risk breast cancer genes, which confer significantly increased risk of breast and ovarian cancer Risk can be mitigated through breast screening10 and/or preventive surgery11 13 131 samples were tested for changes in medically actionable genes, including high risk cancer genes Personal and family (first degree relatives) history of cancer was collected throughout the study Genetic results of relevance Following notification of women with high risk results: 97% made an appointment with a familial cancer centre to discuss results further 97% proceeded with confirmatory genetic testing 60% have undergone risk reducing oophorectomy An average of 3.3 relatives were tested per index case 51% of relatives tested also had the genetic variant 53 participants had a medically actionable result in high risk cancer genes12 No genetic results have been returned as yet At an estimated minimum of 3.3 cascade cases per index case,7 offering the return of results to 53 participants could reach a minimum of 175 Australians at high risk of developing familial cancer ASPREE = ASPirin in Reducing Events in the Elderly. Box 3 – Distribution of age among family members accepting cascade testing through a familial cancer centre (FCC) compared with index cases identified through Lifepool6 Although index cases identified through Lifepool often approach the age at which genetic risk is less relevant, a large proportion of the family members identified are considerably younger, at an age where preventive benefits can be maximised.

Jane Tiller · Alison H Trainer · Ian Campbell · Paul A Lacaze

Managing patients with acute chest pain should include opportunistic discussion of strategies for preventing coronary artery disease

Johannes T Neumann · Andrew M Tonkin

Prostate cancer specialists working in collegiate, multidisciplinary teams are most likely to provide the best outcomes for patients

Henry H Woo · Amy Teh

Objectives: To assess the efficacy of a pro‐active, absolute cardiovascular risk‐guided approach to opportunistically modifying cardiovascular risk factors in patients without coronary ischaemia attending a chest pain clinic. Design: Prospective, randomised, open label, blinded endpoint study. Setting: The rapid access chest pain clinic of Royal Hobart Hospital, a tertiary hospital. Participants: Patients who presented to the chest pain clinic between 1 July 2014 and 31 December 2017 who had intermediate to high absolute cardiovascular risk scores (5‐year risk ≥ 8%). Patients with known cardiac disease or from groups with clinically determined high risk of cardiovascular disease were excluded. Main outcome measures: The primary endpoint was change in 5‐year absolute risk score (Australian absolute risk calculator) at follow‐up (at least 12 months after baseline assessment). Secondary endpoints were changes in lipid profile, blood pressure, smoking status, and body mass index, and major adverse cardiovascular events. Results: The mean change in risk at follow‐up was +0.4 percentage points (95% CI, –0.8 to 1.5 percentage points) for the 98 control group patients and –2.4 percentage points (95% CI, –1.5 to –3.4 percentage points) for the 91 intervention group patients; the between‐group difference in change was 2.7 percentage points (95% CI, 1.2–4.1 percentage points). Mean changes in lipid profile, systolic blood pressure, and smoking status were larger for the intervention group, but not statistically different from those for the control group. Conclusions: An absolute cardiovascular risk‐guided, pro‐active risk factor management strategy employed opportunistically in a chest pain clinic significantly improved 5‐year absolute cardiovascular risk scores. Trial registration: Australia New Zealand Clinical Trial Registry, ACTRN12617000615381 (retrospective).

J Andrew Black · Julie A Campbell · Serena Parker · James E Sharman · Mark R Nelson · Petr Otahal · Garry Hamilton · Thomas H Marwick

Objectives: To describe patterns of care in New South Wales for men with prostate cancer, and to ascertain factors associated with receiving different types of treatment. Design: Individual patient data record linkage study. Setting, participants: 4003 New South Wales men aged 45 years or more enrolled in the population‐based 45 and Up Study in whom prostate cancer was first diagnosed during 2006–2013. Main outcome measures: Prostate cancer treatment type received; factors statistically associated with treatment received; proportions of patients who consulted radiation oncologists prior to treatment. Results: In total, 1619 of 4003 patients underwent radical prostatectomy (40%), 893 external beam radiotherapy (EBRT) (22%), 183 brachytherapy (5%), 87 chemotherapy (2%), 373 androgen deprivation therapy alone (9%), and 848 no active treatment (21%). 205 of 1628 patients who had radical prostatectomies (13%) had radiation oncology consultations prior to surgery. Radical prostatectomy was more likely for patients aged 45–59 years, with regional stage disease, living 100 km or more from the nearest radiotherapy centre, having partners, or having private health insurance, while lower physical functioning, obesity, and living in areas of greater socio‐economic disadvantage reduced the likelihood. EBRT was more likely for patients aged 70–79 years, with non‐localised or unknown stage disease, living less than 100 km from the nearest radiotherapy centre, or not having private health insurance, while the likelihood was lower for patients aged 45–59 years or more than 80 years and for those who had several comorbid conditions. Conclusions: Men with prostate cancer were twice as likely to have radical prostatectomy as to receive EBRT, and fewer than one in seven had consulted radiation oncologists prior to prostatectomy. The treatment received was influenced by several socio‐demographic factors. Given the treatment‐specific side effects and costs, policies that affect access to different treatments for prostate cancer should be reviewed.

Mei Ling Yap · Dianne L O'Connell · David E Goldsbury · Marianne F Weber · David P Smith · Michael B Barton

Many patients had persistent symptoms two months after diagnosis, including fatigue, chest pain, and breathlessness

David R Darley · Gregory J Dore · Lucette Cysique · Kay A Wilhelm · David Andresen · Katrina Tonga · Emily Stone · Anthony Byrne · Marshall Plit · Jeffrey Masters · Helen Tang · Bruce Brew · Philip Cunningham · Anthony Kelleher · Gail V Matthews

Medicare Benefits Schedule (MBS) data indicated that there were 37% fewer screening procedures for breast cancers and 55% fewer for colorectal cancers in April than in March 2020.1 We examined the temporal relationship between coronavirus disease 2019 (COVID‐19)‐related restrictions in Victoria during 1 April – 15 October 2020 and cancer pathology notifications to the Victorian Cancer Registry (VCR), to estimate their impact on cancer diagnoses. Victorian legislation requires pathology services to notify reportable cancer diagnoses to the VCR.2 The E‐Path system, installed in all Victorian pathology services during 2013–2018,3 automatically transmits notifications to the VCR together with pathologist report authorisations. During 2019, 97 313 of 104 025 cancer pathology notifications to the VCR (94%) were received via E‐Path (data supplied by author LB). Changes to the E‐Path system during 2019 meant that we were unable to directly compare notification numbers for 2019 and 2020. We therefore modelled cancer incidence during 2014–2018 by Poisson regression. A spline function was fitted to VCR cancer incidence data for weeks 1–52, adjusted for day type (working or non‐working day/public holiday) and year, and the fitted curve used to predict daily incidence during 7 January – 15 October 2020. Predicted incidence was re‐scaled to estimate expected notification numbers; the scale factor was the number of notifications during the baseline period — 1 February – 16 March 2020, allowing a two‐week washout period before restrictions were formally announced — divided by the predicted incidence during this period. Observed and predicted notification numbers were compared using Poisson regression, with the expected number as an offset term, enabling estimation of relative reductions with 95% confidence intervals (CIs). Differences between predicted and actual notification numbers were estimated, both overall and for specific groups (eg, by tumour or age group), based on the pertinent incidence data. As a single cancer diagnosis can be associated with several pathology notifications, the number of undiagnosed cancers was estimated by multiplying the difference in notification numbers by the ratio of newly diagnosed tumours to pathology notifications in 2018 (Supporting Information, table 1). The confidence interval for the number of undiagnosed cases was based on the Poisson model, keeping the ratio of newly diagnosed tumours to pathology notifications constant. In sensitivity analyses, data were fitted to polynomial models, different baseline periods were used, or data were restricted to reportable cancer diagnoses. The study was exempted from formal ethics review by the human research ethics committee of Cancer Council Victoria. During 1 April – 15 October 2020, there were 5446 fewer notifications of new cancer diagnoses than predicted by our primary model (predicted, 54 609 v observed, 49 163; relative reduction, –10.0%; 95% CI, –10.8% to –9.2%) (Supporting Information, figure 1); we estimated that there were 2530 undiagnosed cancers (95% CI, 2327–2731). The relative reduction was greatest during 1 April – 4 May 2020 (Box 1). By tumour group, the relative reductions were most marked for prostate cancer, head and neck tumours, melanoma, and breast cancer; they were greater for men, people aged 50 years or more, and for people in areas of higher socio‐economic position (Box 2). The pattern of difference in notifications varied between tumour groups (Supporting Information, figure 2). The 6.5‐month period of COVID‐19‐related restrictions in Victoria was accompanied by a 10% reduction in cancer pathology notifications; we estimated that about 2530 cancer diagnoses were either delayed or missed. The impact of delayed diagnosis is greatest for patients with aggressive cancers. Changes in care delivery during the restrictions, including suspension of screening services and outpatient clinics and postponed surveillance of existing cancers, may have affected notification numbers for some tumour groups and consequently the estimated number of delayed diagnoses. Planning for a possible surge in cancer diagnoses over the coming 6–12 months, and media campaigns encouraging people to not further delay seeking medical attention, may ameliorate any negative impact of delayed cancer diagnosis. Box 1 – Cancer pathology notifications to the Victorian Cancer Registry, January–October 2020: observed (red) and predicted numbers (green), by day type LOESS = locally estimated scatterplot smoothing. The grey area marks the baseline period, the vertical dotted lines the analysis period for predicted notifications. A state of emergency was declared in Victoria on 16 March 2020. Stage 3 movement restrictions were applied from 30 March, eased on 13 May, and re‐applied from 8 July. The state of emergency was renewed on 2 August, together with application of stage 4 restrictions to metropolitan Melbourne until their easing from 19 October. For further details, see the footnote to figure 2 in the online Supporting Information. Box 2 – Cancer pathology notifications and estimated numbers of undiagnosed reportable cancers, 1 April – 15 October 2020* table#t2 tbody td:nth-child(n+2) P. Pleft { text-align: center; } Notifications Relative difference (95% CI) Absolute difference (a) Tumour to notification ratio (b) Estimated number of undiagnosed tumours (a*b) Characteristic Predicted Observed All notifications 54 609 49 163 –10.0% (–10.8% to –9.2%) –5446 0.465 2530 Sex† Males 15 458 14 190 –8.2% (–9.7% to –6.7%) –1268 0.427 541 Females 10 408 10 367 –0.4% (–2.3% to 1.5%) –41 0.434 18 Age at diagnosis (years) < 50 9981 9674 –3.1% (–5.0% to –1.1%) –307 0.454 139 50–74 30 949 27 555 –11.0% (–12.0% to –9.9%) –3394 0.447 1516 ≥ 75 13 697 11 934 –12.9% (–14.4% to –11.3%) –1763 0.514 906 Tumour group Breast 7923 7130 –10.0% (–12.1% to –7.9%) –793 0.380 301 Colorectal 5063 4838 –4.4% (–7.1% to –1.7%) –225 0.501 113 Haematologic 10 011 9321 –6.9% (–8.8% to –5.0%) –690 0.234 162 Melanoma 7168 6217 –13.3% (–15.4% to –11.1%) –951 0.538 511 Lung 2967 3062 3.2% (–0.4% to 6.9%) 95 0.483 –46 Head and neck 1363 1155 –15.3% (–20.0% to –10.3%) –208 0.504 105 Bladder 2159 2009 –6.9% (–10.9% to –2.8%) –150 0.370 56 Prostate 6417 4770 –25.7% (–27.8% to –23.5%) –1647 0.560 922 All other 11 931 10 661 –10.6% (–12.3% to –8.9%) –1270 0.546 693 Socio‐economic position (quintile)‡ 1 (most disadvantaged) 10 334 9789 –5.3% (–7.1% to –3.4%) –545 0.453 247 2 10 378 9447 –9.0% (–10.8% to –7.1%) –931 0.456 425 3 10 192 9624 –5.6% (–7.4% to –3.7%) –568 0.488 277 4 10 925 9463 –13.4% (–15.1% to –11.6%) –1462 0.455 665 5 (least disadvantaged) 11 385 9714 –14.7% (–16.4% to –13.0%) –1671 0.460 769 Remoteness¶ Major cities 37 506 33 753 –10.0% (–11.0% to –9.0%) –3753 0.461 1731 Inner regional 13 414 12 031 –10.3% (–11.9% to –8.7%) –1383 0.472 652 Outer regional/remote 2553 2457 –3.8% (–7.5% to 0.1%) –96 0.472 45 CI = confidence interval. * Poisson regression (spline function, adjusted for day type [working day or non‐working day/public holiday] and year; baseline period: 1 February – 16 March 2020). † For cancers common in both sexes (melanoma, colorectal cancer, lung, head and neck cancers, haematological malignancies). ‡ Based on residential address, using the Google Geocoding API (https://developers.google.com/maps/documentation/geocoding/overview), spatially joined to Australian Bureau of Statistics Statistical Area 1 (SA1) polygons.4 Area‐based socio‐economic quintiles were based on 2016 Australian Bureau of Statistics census data.5 ¶ Accessibility and Remoteness Index of Australia.6

Luc te Marvelde · Rory Wolfe · Grant McArthur · Louis A Blake · Sue M Evans

Chakrabarti R, George G, Wells K, Crock C. Characteristics, treatment and complications of herpes zoster ophthalmicus at a tertiary eye hospital. Med J Aust 2020; 213: 226–227. https://doi.org/10.5694/mja2.50554. The author and affiliations list for this Research letter was incomplete. It should read: Rahul Chakrabarti,1 Grace George,1,2 Kristen Wells,1 Carmel Crock,1 Eamonn Fahy1 1 Royal Victorian Eye and Ear Hospital, Melbourne, VIC. 2 Newcastle University, Newcastle‐upon‐Tyne, United Kingdom.

Dudley MJ, Lin PI. Preventing suicide by young people requires integrative strategies. Med J Aust 2021; 214: 125–126. https://doi.org/10.5694/mja2.50939. The second last sentence of the fifth paragraph was incorrect. It should read: However, inadequate knowledge about mental health services is a problem for one‐third of parents and carers who do not obtain the help their children and adolescents with mental disorders need. Also, reference 14 was incorrect. It should read: Lawrence D, Johnson S, Hafekost J, et al. The mental health of children and adolescents: report on the second Australian Child and Adolescent Survey of Mental Health and Wellbeing (here: p. 86). Aug 2015. https://www.health.gov.au/internet/main/publishing.nsf/Content/9DA8CA21306FE6EDCA257E2700016945/%24File/child2.pdf (viewed Dec 2020).

To the Editor: The coronavirus disease 2019 (COVID‐19) pandemic has raised concerns of a subsequent increase in suicides,1 but limited empirical data are available on this topic.2,3 We analysed numbers of suicidal presentations (including suicidal ideation, non‐suicidal self‐injury and suicide attempts) to emergency departments (EDs) within the Gold Coast Hospital and Health Service before and since the spread of COVID‐19 in Queensland, Australia. Cases were identified from ED administrative data through relevant diagnoses, presenting problems and keywords, followed by a manual investigation of triage narratives to exclude false positive cases, such as non‐deliberate injuries or poisonings. The numbers of ED visits between January and August 2020 were compared with the projected numbers, calculated by applying an annual increase of 13.5%4 to presentations during the same period in 2019. From March 2020 onwards, a marked divergence between observed and projected numbers is noted, corresponding to the oscillations in the numbers of diagnosed COVID‐19 cases in Queensland (Box). At the peak of the pandemic, the reductions in suicidal presentations were the largest (29.8% in March and 23.6% in April 2020). Over the next 2 months, daily numbers of diagnosed COVID‐19 cases remained low and the difference between observed and projected numbers gradually narrowed (20.8% in May and 14.6% in June 2020). In July 2020, observed numbers exceeded projected numbers by 11.4%, but then declined again in August 2020, coinciding with another resurgence of COVID‐19. Between March and August 2020, the Gold Coast Hospital and Health Service had 554 less suicidal presentations than expected. The well documented negative impact of COVID‐19 on all aspects of society, including mental health,5 suggests that a substantial reduction of suicide risk during this time is unlikely. Instead, our results may reflect changes in help‐seeking behaviour, with fewer people willing to seek help for suicidality through in‐hospital consultations due to fears of contracting COVID‐19.6 Ongoing promotion of telehealth and enabling safe hospital presentations or alternatives to ED7 is therefore needed to prevent the adverse outcomes of the COVID‐19 pandemic due to delayed access to care. Limitations of this work include potential underestimations of suicidal presentations due to coding issues8 and the inability to differentiate between types of suicidal presentations. Box – Numbers of suicidal presentations to the Gold Coast Hospital and Health Service in 2019 and 2020, and numbers of daily coronavirus disease 2019 (COVID‐19) cases in Queensland, Australia Error ranges for the projected 2020 numbers are 95% confidence intervals.

Jerneja Sveticic · Nicolas JC Stapelberg · Kathryn Turner

To the Editor: Siru and colleagues have raised potential concerns about the strategy recommended by the Australian Diabetes Society (ADS) and other peak bodies to diagnose gestational diabetes (GDM) during the coronavirus disease 2019 (COVID‐19) pandemic.1 In their study, 46% of subjects diagnosed with GDM had a fasting blood glucose level (BGL) < 4.7 mmol/L but elevated post‐load blood glucose levels, and would be missed by the ADS‐recommended strategy. The authors suggested that this exposes women and their newborns to significant risks with the potential for significant harm. No outcome data were provided to justify these assertions. Evidence from the Hyperglycemia and Adverse Pregnancy Outcome (HAPO) study suggests that such women do not have increased rates of pregnancy‐associated complications.2,3,4,5 The subgroups with the highest odds ratios for newborns who were large for gestational age had an elevated fasting BGL and any elevation of post‐load BGL (odds ratio > 3), whereas subgroups having only elevated fasting or post‐load BGL had a considerably lower odds ratio, equivalent to the diagnostic threshold for GDM of 1.75.2 Further, women with a fasting BGL < 4.5 mmol/L had low rates of some complications irrespective of their post‐load BGL.3 A subsequent analysis of 6128 patients from five centres involved in the HAPO study did not observe any increase in pregnancy‐associated complications in women with a fasting BGL below the 75th centile (4.6 mmol/L).4 A recent analysis of 5974 women in the HAPO study assessed the ADS‐recommended COVID‐19 GDM strategy and reported no increase in any complication.5 There were fewer cases of pregnancy‐associated hypertension and caesarean delivery, with similar rates of large‐for‐gestational‐age newborns and neonatal hypoglycaemia. These data provide reassurance. There is no evidence of harm. When this strategy is used, women with a fasting BGL < 4.7 mmol/L are spared being labelled with GDM and do not require education, monitoring, more frequent follow‐up or transfer to specialist services, freeing up valuable health care resources. Importantly, they will not be advised to inappropriately restrict their dietary intake or commence therapy with insulin or metformin with the potential for harm. An initial fasting BGL test would eliminate the need for a pregnancy oral glucose tolerance test in the majority of women, identifying a smaller group of women at risk of pregnancy‐associated complications where management can be more appropriately targeted.

Michael C d'Emden · Jacobus PJ Ungerer · Susan J Jersey

To the Editor: We read with interest the analysis and comments by Shand and colleagues.1 The authors show a rise in the dispensing of intravenous iron agents in the period from 2013 to 2017 for women. They suggest that this may be an issue relating to the inappropriate use of this agent. However, we question whether the data can support this suggestion, and feel this should be viewed cautiously because of the study limitations. The study did not examine the reasons for the escalation in prescriptions. The rise in numbers is not surprising. Iron deficiency anaemia is common and undertreated.2 While dietary modifications and oral iron are the first line treatment, oral iron is limited by the high occurrence of side effects in up to 50% of users.3 The new intravenous agents allow a full treatment in one visit — often in primary care — which is safe and effective. The authors are rightly concerned about safety; however, it is reassuring that studies have demonstrated the relative safety of these agents.4 During the study period, ferric carboxymaltose became more widely available, with its listing on the Pharmaceutical Benefits Scheme easing a financial barrier to women who need treatment. A number of education programs and various patient blood management initiatives to detect and treat iron deficiency that occurred during the study period could influence the study findings. A noteworthy activity was the landmark Patient Blood Management Collaborative facilitated by the Australian Commission on Safety and Quality in Health Care.5 The assumption by the authors that the number of women receiving treatment is equivalent to the number of dispensing claims by pharmacy is likely incorrect, as there are situations when an individual can have multiple dispensing claims. The study is timely because it highlights a serious condition affecting a large proportion of Australian women that must be better managed. Despite the various endeavours to improve access to treatment for women, iron deficiency remains undertreated and under‐recognised.

Pradeep Jayasuriya · Toby Richards · Bernd Froessler

In reply

Antonia W Shand · Natasha Nassar

To the Editor: This retrospective population‐based study aimed to determine the incidence of type 2 diabetes from 2012 to 2019 in Western Australian youth aged under 16 years, and to examine temporal trends between 2000 and 2019, using data from the Western Australian Children’s Diabetes Database (WACDD).1 The data extracted for eligible patients diagnosed with type 2 diabetes, according to standard criteria,2 included diagnosis year, age, sex and self‐reported Aboriginal or Torres Strait Islander status. Poisson regression was used to determine incidence rates and trends by calendar year, sex, and Aboriginal or Torres Strait Islander status. This study received ethics approval from the Western Australian Child and Adolescent Health Service Human Research Ethics Committee (RGS0000002386). To ensure the validity of our findings, a secondary aim was to estimate completeness of the WACDD for type 2 diabetes diagnosed in patients aged under 16 years from 1999 to 2016. For this purpose, we used the capture–recapture method with two independent sources: the primary source was WACDD, and the secondary source was the National Diabetes Services Scheme (NDSS) database.3 We identified 224 eligible cases from WACDD (2000–2019), of which 129 (58%) were girls and 128 (57%) were Aboriginal or Torres Strait Islander children. The mean age at diagnosis of type 2 diabetes was 13.2 years (standard deviation, 2.0 years), with no differences observed by sex or Aboriginal or Torres Strait Islander status. The overall mean incidence was 2.3/100 000 (95% CI, 2.1–2.7), with an average annual increase of 5.2% (95% CI, 2.8–7.8%). No differences were observed in the mean incidence or incidence rate trends between boys and girls. The mean incidence in Aboriginal or Torres Strait Islander children was 18‐fold higher (incidence rate ratio, 18.31; 95% CI, 14.05–23.86) than in non‐Aboriginal or Torres Strait Islander children (Box). In addition, the incidence increased by an annual average of 6.2% (95% CI, 2.8–9.6%) in Aboriginal or Torres Strait Islander children compared with 3.9% (95% CI, 0.3–7.6%) in non‐Aboriginal or Torres Strait Islander children (Box). Of the 170 eligible cases identified in the WACDD, 107 were ascertained from both WACDD and NDSS, 40 from NDSS only, and 63 from WACDD only. Using the capture–recapture method,3 the WACDD was estimated as 73% complete. This study provides further evidence for the growing incidence of type 2 diabetes in Australian children and highlights the urgent need for community, public health providers, and government to address this disease and its significant burden in young people.4,5 Box – Case numbers, person years of observation, mean incidence (95% CI) and average annual increase in incidence (95% CI) by Aboriginal or Torres Strait Islander status for youth aged under 16 years diagnosed with type 2 diabetes in Western Australia (2000–2019) Non‐Aboriginal or Torres Strait Islander Aboriginal or Torres Strait Islander Combined Cases 96 (43%) 128 (57%) 224 (100%) Sex, female 54 (56%) 75 (59%) 139 (58%) Mean age at diagnosis (SD), years 13.6 (1.8) 13.0 (2.1) 13.2 (1.9) Age range at diagnosis, years 6.9–15.9 6.8–15.9 6.8–15.9 Total person years 8 884 383 644 157 9 528 540 Mean annual incidence (95% CI) per 100 000 person years 1.1 (0.9–1.3) 19.9 (16.6–23.6) 2.3 (2.1–2.7) Average annual increase in incidence (95% CI) 3.9% (0.3–7.6%) 6.2% (2.8–9.6%) 5.2% (2.8–7.8%) CI = confidence interval; SD = standard deviation.

Aveni Haynes · Jacqueline A Curran · Elizabeth A Davis

To the Editor: The Australian Therapeutic Goods Administration (TGA) categorisation system for prescribing medicines in pregnancy lists doxylamine as a Category A medicine — “Drugs which have been taken by a large number ofpregnantwomen … without any proven increase in the frequency of malformations”.1 However, despite this categorisation, many single‐ingredient non‐prescription doxylamine products continue to carry misleading product and consumer information. While correctly assigning Category A, they then contradictorily include warnings such as “do not use during pregnancy” and/or “studies to prove it is safe for the developing baby have not been done”. There is no validity or justification to such statements, which are inconsistent with both available data and the Category A status. Studies on the safety of doxylamine in pregnancy date from the 1980s, when the first meta‐analysis demonstrated that doxylamine was not a human teratogen and should not have been removed from the market by the manufacturer.2 Subsequently, there have been several studies, reinforcing both the safety and efficacy of doxylamine for the treatment of nausea and vomiting in pregnancy (NVP).3 This resulted in the United States Food and Drug Administration (FDA) once again approving doxylamine (with pyridoxine) in 2014 as safe to use in pregnancy, with a specific indication for managing NVP. Furthermore, the Society of Obstetric Medicine of Australia and New Zealand’s practice guidelines recommend doxylamine (and pyridoxine) as first line treatment for NVP.4 MotherSafe — a New South Wales‐based teratogen information service — receives about 20 000 calls annually from health care providers and consumers. Many women call this service after receiving conflicting advice about using doxylamine in pregnancy from pharmacists and other health care professionals, including general practitioners and obstetricians. Moreover, pharmacists also identify a knowledge gap and concerns about off‐label use and discrepancies between the product information, categorisation and other available information sources.5 In some cases, pharmacists have refused to sell doxylamine to women with NVP because of the product information, considering the use of doxylamine for NVP to be off‐label and thus not indicated or safe. Despite raising our concerns with the TGA about the confusing labelling, we are yet to see any progress in correcting this significant misinformation among health professionals and patients. This specific issue highlights wider concerns around Australia’s confusing pregnancy risk classification and the imperative for the TGA to abandon the current alphabetical categorisation and move to a format similar to the one used by the FDA Pregnancy and Lactation Labeling Rule, which requires all packaging and consumer information to include consistent evidence‐based information on medication use in pregnancy and breastfeeding.6

Debra S Kennedy · Ronald P Batagol